FDA Approves Datroway for Pretreated Advanced Breast Cancer

Oncology/Hematology
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Breast Cancer

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In trial, datopotamab deruxtecan increased progression-free survival by 2 months

by
Mike Bassett, Staff Writer, MedPage Today
January 17, 2025

The FDA approved datopotamab deruxtecan (Datroway) for adults with unresectable or metastatic, hormone receptor (HR)-positive/HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

Efficacy of the Trop2-directed antibody and topoisomerase inhibitor conjugate was evaluated in the multicenter TROPION-Breast01 trial, which included 732 patients randomized to datopotamab deruxtecan or investigator’s choice of chemotherapy. Participants must have experienced disease progression, been ineligible for further endocrine therapy, and received one or two prior lines of chemotherapy for unresectable or metastatic disease.

The trial met its primary endpoint, with a median progression-free survival (PFS) of 6.9 months in the datopotamab deruxtecan arm versus 4.9 months in the chemotherapy arm (HR 0.63, 95% CI 0.52-0.76, P